Bitter Tastants and Reflux

Gastro Esophageal Reflux Clinical Trial

Official title:

The Relationship Between Acute Administration of a Bitter Compound and Transient Lower Esophageal Sphincter Relaxations and Reflux Events in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03777787
• Other study ID #: S61251
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: May 10, 2019

Study information

• Verified date: June 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recently the relationship between intragastric pressure (IGP) and reflux events after a meal was investigated, both in gastro-esophageal reflux disease (GERD) patients and in healthy volunteers. Ingestion of a meal was accompanied by a drop in IGP. However, the magnitude of this drop varied and was inversely correlated with the number of transient lower esophageal sphincter relaxations (TLESRs) and the number of reflux events, both in patients and in healthy volunteers: a smaller meal-induced drop in IGP was associated with a higher rate of reflux events and vice versa. This finding suggests that a smaller meal-induced drop may act as a trigger for reflux. It has been demonstrated that bitter administration leads to a smaller meal-induced drop. Therefore, bitter can be a dietary trigger for TLESRs facilitating the occurrence of symptoms of GERD. To evaluate this hypothesis, the researchers will study the relationship between bitter and the occurrence of TLESRs and reflux events in healthy volunteers. Additionally, it has been demonstrated that administering bitter also influences the concentration of motilin. Therefore, the research team will also measure the concentration of motilin to investigate whether changes in motilin concentrations can influence the number of TLESRs, via a change in gastric tone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 10, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy female volunteers

• Age between 18 and 65

• Written informed consent

Exclusion Criteria:

• A history of any upper GI symptoms or GI surgery;

• Psychological disorders;

• Concomitant use of other medication or treatments except for oral contraceptives;

• Use of medication altering esophageal or GI motility;

• Pregnant or nursing women.

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Intervention

Dietary Supplement:
• Denatonium Benzoate
A single intragastric administration of denatonium benzoate (1 µmol/kg)
• Water
A single intragastric administration of water

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of TLESRs	Changes in the number of transient lower esophageal sphincter relaxations (TLESRs) between the placebo and bitter condition.	1 week
Secondary	Change in reflux	The change in the number of reflux events between placebo and bitter condition.	1 week
Secondary	Change in motility pattern	The change in the intragastric pressure between placebo and bitter condition.	1 week
Secondary	Change in motilin concentration	The change in motilin concentration between placebo and bitter condition.	1 week
Secondary	Change in symptoms	Change in the number of volunteers reporting gastrointestinal symptoms between placebo and bitter condition	1 week